VivaVision Biotech reports positive Phase 2 trial results of VVN461 for postoperative inflammation treatment following cataract surgery

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VivaVision Biotech has announced positive topline results from its U.S. Phase 2 clinical trial evaluating VVN461-CS-201, a potent nonsteroidal dual JAK1/TYK2 immunomodulator, for the treatment of postoperative inflammation following cataract surgery.

The multicenter, randomized, double-masked, vehicle-controlled study enrolled 91 participants who underwent routine unilateral cataract extraction with phacoemulsification and lens replacement (CELR). Participants were randomized into three groups: VVN461 1.0%, VVN461 0.5%, and vehicle. Each group received four daily doses (QID) over 14 days. VVN461 demonstrated both statistical and clinical improvements in primary and several secondary endpoints compared to the vehicle group.¹

These findings support the potential of VVN461 as an effective treatment option for managing inflammation after cataract surgery. Key findings include:

• Primary Endpoint: At Day 14, 60.0% (18/30) (1.0%) and 53.3% (16/30) (0.5%) of subjects in the VVN461 groups achieved anterior chamber cell (ACC) Grade 0 compared to 19.4% (6/31) in the vehicle group (p=0.0012 and p=0.0057, respectively.)
• Secondary Endpoints: Clinically and statistically significant reductions in anterior chamber flare (ACF) and subject-reported ocular pain, with therapeutic effects observed as early as Day 3.
• Exploratory Findings: Over the 14 days of the study, only 4 subjects (combined active groups) out of 61 in the VVN461 groups required rescue medication, compared to 15 out of 30 in the vehicle group, indicating faster and more effective post-operative healing and improved baseline ocular comfort.

The adverse event rate with both concentrations of VVN461 was low, with only mild severity, and similar to its vehicle, confirming VVN461’s safety profile.

"VVN461’s Phase 2 results highlight its potential as a safer alternative to corticosteroids for post-operative inflammation," said Jason Bacharach, MD, founder and director of research at North Bay Eye Associates. "The positive efficacy of VVN461, combined with its excellent safety profile, addresses a critical need for anti-inflammatory therapies with fewer corticosteroid-associated risks."

Traditional corticosteroid eye drops are effective but can cause adverse effects, including increased intraocular pressure, delayed wound healing, and ocular infections, particularly with prolonged use. VVN461 presents a promising alternative, utilizing its targeted, nonsteroidal mechanism to reduce these risks while maintaining strong anti-inflammatory efficacy.¹

“VVN461 represents a meaningful step forward in ophthalmic anti-inflammatory therapy,” said Wang Shen, PhD, CEO of VivaVision. “The reductions in inflammation and ocular pain observed as early as Day 3, combined with a favorable safety profile, underscore the potential impact of this therapy for patients. These results provide a strong foundation to advance our efforts around a Phase 3 clinical trial of VVN461 in the U.S.”

According to the company, it also is conducting Phase 2 studies for VVN461 in non-infectious anterior uveitis in China.

Reference

1. VivaVision announces positive topline results from Phase 2 trial of VVN461 for post-operative inflammation following cataract surgery [news release]. GlobeNewswire. December 4, 2024. Accessed December 4, 2024. https://www.globenewswire.com/news-release/2024/12/04/2991736/0/en/VivaVision-Announces-Positive-Topline-Results-from-Phase-2-Trial-of-VVN461-for-Post-Operative-Inflammation-Following-Cataract-Surgery.html